EP2455116B1 - Device for the continuous monitoring of characteristic blood quantities in extracorporeal circulation circuit - Google Patents

Device for the continuous monitoring of characteristic blood quantities in extracorporeal circulation circuit Download PDF

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Publication number
EP2455116B1
EP2455116B1 EP11189430.9A EP11189430A EP2455116B1 EP 2455116 B1 EP2455116 B1 EP 2455116B1 EP 11189430 A EP11189430 A EP 11189430A EP 2455116 B1 EP2455116 B1 EP 2455116B1
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EP
European Patent Office
Prior art keywords
sensor
micro processor
display screen
quantities
fact
Prior art date
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Active
Application number
EP11189430.9A
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German (de)
English (en)
French (fr)
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EP2455116A1 (en
Inventor
Nicola Ghelli
Stefano Foschieri
Antonio Petralia
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Eurosets SRL
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Eurosets SRL
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3607—Regulation parameters
    • A61M1/3609—Physical characteristics of the blood, e.g. haematocrit, urea
    • A61M1/361—Physical characteristics of the blood, e.g. haematocrit, urea before treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3607—Regulation parameters
    • A61M1/3609—Physical characteristics of the blood, e.g. haematocrit, urea
    • A61M1/3612—Physical characteristics of the blood, e.g. haematocrit, urea after treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3666—Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/32—Oxygenators without membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3334—Measuring or controlling the flow rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3368—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502—User interfaces, e.g. screens or keyboards
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics
    • A61M2230/205—Blood composition characteristics partial oxygen pressure (P-O2)

Definitions

  • the invention relates to a device for the continuous monitoring of characteristic blood quantities in extracorporeal circulation circuit.
  • one of the appliances included in the extracorporeal circuit consists of an oxygenator device in which the blood coming from the venous line of withdrawal from the patient is enriched with oxygen before being introduced into the arterial return-to-the-patient line.
  • the proposed aim is achieved by a device for the continuous monitoring of characteristic blood quantities in extracorporeal circulation circuit, according to the invention, characterized by the fact that it comprises the characteristics indicated in the following claims.
  • figure 1 which shows in schematic form an extracorporeal circulation circuit with the device according to the invention
  • figure 2 which shows one among the various images that can appear on the display screen of the monitoring appliance, or simply monitor, as it will be called henceforth, included in said device, according to what is shown in the description of operation.
  • the same image also enables us to indicate how, on the display screen, two forms of representation appear of the data coming from the micro processor included in the device according to the invention: a representation in numerical form in the boxes at the top and bottom edges, and a representation in graphic form in the central field.
  • this represents the extracorporeal circulation circuit with a venous line 1 which conveys the blood from the patient 2 to the oxygenator 3, and an arterial line 4 which conveys the blood back to the patient.
  • the device according to the invention comprises the monitor globally indicated by 5, equipped with the micro processor 6 connected by means of the indicated dash and dot lines to the sensors which we shall immediately describe in detail, and which is also equipped with the display screen 7.
  • the first sensor is that indicated by 8 fitted to the patient 2 to measure his/her average PMP pressure which appears in the first box on the right at the bottom edge of the display screen.
  • This sensor 8 is of the type of a pressure transducer which is fitted to the patient in order to read his/her arterial pressure and consequently both the systolic pressure and the diastolic pressure.
  • the sensor 8 is operatively connected to the micro processor 6, which is programmed to calculate the average PMP pressure of the patient on the basis of an algorithm of a type known to the technician of the sector.
  • the micro processor 6 is suitable for calculating the average PMP pressure on the basis of the maximum and minimum pressures read by the sensor 8 within a preset time interval.
  • the sensor 9 and the sensor 10 measure the lactates and the glycaemia respectively, and the related data appear in the first two boxes on the left on the lower edge of the display screen.
  • the three sensors 11, 12, 13 are suitable for measuring the three quantities "arterial saturation of the oxygen", blood flow and arterial blood temperature respectively, and the related data appear in the group of three boxes marked SAT A, C.O., TEMP A on the lower edge of the display screen.
  • the "optional flow sensor" 14 will be fitted in the circuit in a position distant from the sensor 12, and the data read by it prevail, if it is connected to the micro processor 6, over the data coming from the sensor 12, and will therefore appear in the related box of the display screen.
  • the three sensors 15, 16, 17 are suitable for measuring the three quantities "venous saturation of the oxygen", haemoglobin and venous blood temperature respectively, and the related data appear in the group of three boxes marked SAT V, Hb, TEMP V on the lower edge of the display screen.
  • the sensors 18 and 19 are installed at distant points of the circuit for measuring the blood pressure, and the related data appear in the two boxes at the lower edge of the display screen marked P1 and P2.
  • the senor 20 is suitable for further measuring the blood temperature, and the related data appear in the box marked TEMP E at the lower edge of the display screen.
  • the pair of sensors 11, 13 and the pair of sensors 15, 17 are necessarily meant to be connected on the arterial line and on the venous line of the circuit respectively, being able to be fitted at any points of the lines themselves or integrated in respective probes integrated in the structure of the oxygenator, while all the other sensors, with the sole obvious exception of the sensor which measures the average pressure of the patient, can be fitted indifferently at any points of the circuit.
  • the senor 15 is fitted in correspondence to the inlet connector of the venous line 1 in the oxygenator 3 together with one of the two sensors 12, 16, while the sensor 11 is fitted in correspondence to the outlet connector of the arterial line 4 from the oxygenator 3 together with the other of the two sensors 16, 12.
  • the sensors 12 and 16 can be fitted indifferently at any points of the lines 1, 4.
  • the micro processor 6 is suitable for receiving the measured data at least from the sensors 11, 12, 15, 16 and the data entered by the operators by means of the relative entering means, making them appear at least in part on the display screen 7 and processing them, calculating at least some of the quantities deducible from them, making them appear on the display screen itself.
  • the micro processor 6 is programmed to display in numerical form on the display screen 7 the values of all the quantities measured and calculated, and in graphic form, i.e., by means of diagrams, at least some of such values.
  • the micro processor 6 has means suitable for calculating the quantities derivable from the detected quantities and from those entered by the operator.
  • the micro processor 6 comprises means suitable for calculating at least one of the following quantities chosen from the group comprising: the quantity known by the code BSA relating to the corporeal surface of the patient, the quantity known by the code D02 relating to the quantity of transported oxygen, the quantity known by the code V02 relating to the quantity of oxygen consumed at tissue level, the quantity known by the code 02ER relating to the fraction of extraction of the oxygen, the quantity known by the code SVR relating to the systemic vascular resistance, the quantity known by the code C.I. relating to the cardiac index, the quantity known by the code ⁇ P relating to the difference between the two pressure values.
  • the micro processor 6 also comprises means suitable for creating an archive of data relating to various monitoring procedures.
  • micro processor 6 comprises means suitable for creating an archive of different perfusion programmes.
  • the first box is that identified by the code BSA relating to the patient's corporeal surface, which is calculated on the basis of data which are entered by the operator and consist of the patient's weight and height.
  • the indexed quantities D02i, V02i, 02ERi and SVRi correspond to the quantities D02, V02, 02ER and SVR respectively, split up by the body surface of the BSA patient.
  • the graphic representation is also important of a number of quantities chosen from among those which appear represented in numerical form according to what has been previously illustrated, and by way of example only, in the display screen image in figure 2 , the pattern of the three quantities DO2i, V02i and 02ERi appears in the form of a diagram according to time. But this, we repeat, is only an example, and in this respect, we refer to the description of the operation which immediately follows dedicated to illustrating the operating options provided to operators on the basis of the measurements taken by means of the described sensors.
  • the micro processor 6 also has means suitable for triggering an alarm signal relating to quantities selected by the operator when the values of same are outside an acceptable range, following the entering of the relevant maximum and minimum values by the operator.
  • the monitor 5 While the surgical operation is being prepared, the monitor 5 is switched on and, on the display screen 7, the INITIAL PAGE appears which is visible in figure 3 .
  • the image in figure 4 appears on the display screen with monitoring data previously obtained from other patients, which can be used for reference purposes; after selecting the data of interest, the OK key must be pressed and the "main screen" image of the selected case appears, which we previously called MS1.
  • the OK key After entering the data, the OK key must be pressed to return to the INITIAL PAGE of figure 3 in which the MS1 key is pressed.
  • the operator in the MS1 of figure 2 presses the BSA key, and the image of figure 6 thus appears; after the patient's weight and height data have been entered using the keyboard, the calculated BSA value appears.
  • the extracorporeal circulation can begin, and with it the monitoring, thanks to the transmission of data to the micro processor by all the sensors described above: at a certain point of operation, the display screen will show an image of the MS1 like that of figure 7 , with the graphs and the instantaneous values of the various quantities monitored in the single boxes, updated for example, as previously said, every five seconds.
  • the micro processor 6 has means for displaying, on the display screen 7, in graphic form, at least one quantity by means of diagram of same, which is represented on the axis of ordinates, as a function of time, which is represented on the axis of abscissas.
  • the operator could be interested in knowing, in particular, the V02i pattern according to time: he/she then presses the V02i key and the image of figure 8 appears on the display screen.
  • the micro processor 6 comprises means for displaying a diagram on the display screen 7 having in abscissa the quantity D02i and in ordinate the quantity V02i.
  • the graph itself shows an increase of V02i with the increase of D02i this means that the consumption of oxygen by the patient is higher than that supplied to him/her, if the graph shows a constant pattern of V02i with the increase of D02i, a perfect balance exists between the oxygen consumed and that supplied, and finally, if the graph shows a drop in V02i with the increase of D02i, this means that more oxygen than necessary is being supplied in what is in any case a safety situation.
  • the display means are programmed to represent the lines indicating an increase in V02i with an increase of D02i with a first colour, e.g., red, so as to highlight a dangerous situation and to represent the lines indicating a constant pattern of VO2i with the increase of D02i with a second colour different from the first colour, e.g., green, so as to highlight a safe situation.
  • a first colour e.g., red
  • a second colour different from the first colour e.g., green
  • the display means can be programmed to represent the lines of the diagram which indicate a drop in V02i with the increase of DO2i with the first or with the second colour.
  • This colour variation in accordance with the pattern of V02i with the variation of D02i permits providing the medical staff performing the operation with immediate and easy-to-understand information relating to the relation between the oxygen consumed by the patient and that supplied to the patient, without necessarily having to observe the graph pattern in detail.
  • Such graphic representation is therefore intuitive and of immediate interpretation, technically contributing to facilitate the work of the medical operator.
  • the NAVIGATION FUNCTION key is pressed, and the image of figure 10 appears showing three symbols, and more precisely the symbol 1) with a completely black line, the symbol 2) with the section of line a) green, the symbol 3) with the sections of lines a) and b) green.
  • Alarms can be entered relating to other quantities only at min and max value level, operating as follows.
  • the INITIAL PAGE key is pressed and the image of figure 3 appears, in which the SET UP key is pressed so as to make the image of figure 11 appear, which shows the list of alarms which can be entered.
  • One of the keys of the ALARMS column is pressed, e.g., the key marked SAT V, and the image of figure 12 appears.
  • the path is completed in the opposite direction: when the OK key of the image of figure 12 is pressed, the image of figure 11 appears in which the OK key is pressed to make the image of figure 3 appear; when the MS1 key is pressed in this, the image of figure 7 reappears.
  • the OK key After choosing at most five quantities, the OK key must be pressed, thus determining on the display screen the appearance of a new MS1 form in which appear the quantities chosen in graphic form, therefore from one to five graphs, obviously in addition to all the values in the boxes updated every five seconds.
  • the image of figure 15 appears which comprises miniaturised, besides the image of MS1, four other images of different graphs which can be referred to in enlarged form by pressing the relative keys M2, M3, M4, M5 obtaining the images of the figures 16, 17 , 18, 19 respectively.
  • M2 comprises graphs of quantities included among those listed in figure 13 .

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pulmonology (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)
  • External Artificial Organs (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
EP11189430.9A 2010-11-23 2011-11-16 Device for the continuous monitoring of characteristic blood quantities in extracorporeal circulation circuit Active EP2455116B1 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
ITMI2010A002157A IT1402885B1 (it) 2010-11-23 2010-11-23 Dispositivo per il monitoraggio continuo di grandezze caratteristiche del sangue in circuito di circolazione extracorporea.

Publications (2)

Publication Number Publication Date
EP2455116A1 EP2455116A1 (en) 2012-05-23
EP2455116B1 true EP2455116B1 (en) 2016-04-20

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IT (1) IT1402885B1 (it)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8888730B2 (en) * 2012-09-19 2014-11-18 Sorin Group Italia S.R.L. Perfusion system with RFID feature activation
ES2526254B1 (es) * 2013-07-03 2015-12-18 Salvador Merce Vives Equipo autónomo para cirugía y asistencia cardiaca que genera flujo fisiológico pulsátil y sincronizable
IT201800002461A1 (it) * 2018-02-07 2019-08-07 Eurosets Srl Dispositivo per il monitoraggio continuo di grandezze caratteristiche del sangue in circuito esterno di supporto cardiocircolatorio
WO2020208258A1 (en) 2019-04-12 2020-10-15 Universität Bern Method, device and computer program for estimating a pulmonary blood flow of a subject

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6228033B1 (en) * 1997-05-14 2001-05-08 Tiit Koobi Apparatuses and methods for a noninvasive measurement of physiological parameters

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4401431A (en) * 1981-06-26 1983-08-30 Arp Leon J Blood pump and oxygenator monitor-controller and display device
WO2002026288A2 (en) * 2000-09-27 2002-04-04 Cobe Cardiovascular, Inc. Disposable cartridge for a blood perfusion system
US7335334B2 (en) * 2003-01-14 2008-02-26 Medtronic, Inc. Active air removal from an extracorporeal blood circuit
WO2009049235A2 (en) * 2007-10-12 2009-04-16 Deka Products Limited Partnership Systems, devices and methods for cardiopulmonary treatment and procedures

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6228033B1 (en) * 1997-05-14 2001-05-08 Tiit Koobi Apparatuses and methods for a noninvasive measurement of physiological parameters

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Publication number Publication date
ITMI20102157A1 (it) 2012-05-24
IT1402885B1 (it) 2013-09-27
EP2455116A1 (en) 2012-05-23

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